ANOTHER VIEW

Half-measures won’t do to keep doctors ‘clean’

Sunday, October 12, 2008

Say it ain’t so, Charlie! You got $3,500 for a Paxil talk at the Citrus Club in Orlando; $3,000 for a speech on the same drug at a resort in Jackson Hole; $10,500 for three more in Las Vegas. In total, $2.8 million in consulting fees over eight years, much of it not reported to Emory University, in violation of federal regulations and assurances he gave school administrators. That’s the distressing tale of Dr. Charles Nemeroff, recently forced by revelations of these nondisclosures to step down as chair of Emory’s Department of Psychiatry and Behavioral Sciences.

While he led a government-industry collaborative clinical trial involving one of GlaxoSmithKline’s antidepressants, Nemeroff repeatedly concealed his Glaxo-funded extracurricular financial compensation. On multiple occasions, Nemeroff assured Emory that he did not exceed the federal regulatory threshold of $10,000, even as he took in up to $170,000 a year from the company.

This was not Nemeroff’s first brush with nondisclosure. We at Public Citizen have long opposed a now-discredited device for serious depression called vagus nerve stimulation made by Cyberonics. Yet, in the midst of this debate, an article appeared in Neuropsychopharmacology, authored by eight leading academics led by Nemeroff, saying the device “appears to be a valuable addition to existing treatments.”

Not so fast! As the Wall Street Journal revealed, the article was actually ghost-written by a Cyberonics employee, and none of the eight academics disclosed any conflicts, although all were consultants to Cyberonics. Nemeroff, in particular, should have known better: He was the editor of the journal, which required such disclosures. Although he was forced to resign, the article remains in the medical literature. There is no telling how many doctors were swayed toward inserting this ineffective device into unsuspecting patients.

It might be tempting to write off Nemeroff as a bad apple. But investigations by the U.S. Senate Finance Committee have identified several other prominent academics who failed to disclose the enormous sums of industry largess they accepted.

The problem is the notion that disclosure alone is a panacea for conflict of interest. Disclosure amounts to an evasion of responsibility because the consumer of the disclosed information then becomes responsible for interpreting it. Is a talk by a presenter who has received $30,000 from a sponsor twice as tainted as one by a presenter who has accepted $15,000?

Certain relationships are so egregious that no amount of disclosure will suffice. For instance, investigators in clinical trials should have no direct financial interest in the products they are investigating.

There should also be a low ceiling on total external payments to academics. What assurance did Emory have that Nemeroff was fulfilling his responsibilities as department chair if he was continually jetting off to extol Paxil’s virtues?

Congress is considering bills that would create a database of drug and device companies’ payments to physicians. But the legislation has been watered down to garner support from drug companies and organized medicine. Meanwhile, some leading medical schools, such as the universities of Pennsylvania and Massachusetts, are taking the initiative, implementing stringent policies that restrict the relationships between physicians and industry.

But these efforts remain voluntary and compliance is likely to be spotty. To restore public trust, doctors will have to “just say no” to drug company trinkets, medical schools should keep companies out of clinics and insulate company-funded research from meddling, and government must develop policies that stamp out the worst excesses. Mere disclosure will not suffice.

• Dr. Peter Lurie is deputy director of the Health Research Group at Public Citizen. Jonas Hines is research associate at Public Citizen.

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